# US 2014/0360404 A1 · Acid resistant banding solution for acid resistant two piece hard capsules > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0360404 A1 - Document ID: US20140360404A1 - Status: Published application - Kind: A1 - Application number: 14/357,202 - Filed: 2012-11-08 - Published: 2014-12-11 - Earliest claimed: 2011-11-09 - Assignees: Capsugel Belgium NV - Applicants: Capsugel Belgium NV - Inventors: Xiongwei He; Dominique Nicolas Cade - Web page: https://patentgrep.com/patent/US20140360404A1 ## CPC - A61K 9/4883: {Capsule finishing, e.g. dyeing, aromatising, polishing} - A23P 10/30: Encapsulation of particles, e.g. foodstuff additives - A61K 9/4808: {characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release (capsules filled with granules or microparticles A61K9/16; filled with microcapsules or coated microparticles A61K9/50; with mixture of different granules, microcapsules, (coated) microparticles A61K9/5084)} - A61K 9/4816: {Wall or shell material} - A61K 9/4891: {Coated capsules; Multilayered drug free capsule shells (with drug coating for immediate release A61K9/4808; osmotic devices A61K9/0004)} - A61K 31/167: having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol - A23V 2002/00: Food compositions, function of food ingredients or processes for food or foodstuffs - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A23P: SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS - A23V: INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION ## Abstract The present disclosure relates to acid resistant banding solutions for two piece hard capsules endowed with acid resistant properties, and methods of making and using acid resistant banding solutions. The present disclosure also relates, in part, to methods for banding such acid resistant capsules which provides an acid resistant seal between the capsules parts and achieves increased acid resistance in vitro. ## Claims ### Claim 1 An acid resistant banding composition for acid resistant two piece hard capsules, comprising at least one acid resistant polymer, at least one alkaline compound, and water. ### Claim 2 (depends on 1) The composition according to claim 1, wherein the acid resistant polymer is selected from the group consisting of methacrylic acid copolymers, cellulose acetate phthalate (CAP), cellulose acetate trimellitate (CAT), hydroxypropyl methylcellulose acetate succinate (HPMCAS), hydroxypropyl methylcellulose phthalate (HPMCP), carboxy methyl ethyl cellulose (CMEC), polyvinyl derivatives, and mixtures thereof. ### Claim 3 (depends on 1) The composition according to claim 1, wherein the at least one alkaline compound is selected from the group consisting of sodium bicarbonate, sodium carbonate, potassium carbonate, potassium bicarbonate, sodium hydroxide, tri sodium phosphate, sodium perborate, potassium hydroxide, lithium hydroxide, lithium carbonate, lithium bicarbonate, ammonium carbonate, ammonium bicarbonate, ammonium hydroxide, ammonia, and mixtures thereof. ### Claim 4 (depends on 1, 2, 3) The composition according to any one of claims 1 to 3, further comprising at least one pharmaceutically acceptable or food acceptable plasticizer and/or coloring agent. ### Claim 5 (depends on 1, 2, 3) The composition according to any one of claims 1 to 3, wherein the composition has a viscosity from about 50 cP to about 10,000 cP at room temperature. ### Claim 6 (depends on 5) The composition according to claim 5, wherein the viscosity is from about 100 cP to about 5000 cP. ### Claim 7 (depends on 6) The composition according to claim 6, wherein the viscosity is from about 1500 cP to about 3100 cP. ### Claim 8 (depends on 1) The composition according to claim 1, wherein the at least one acid resistant polymer is hydroxypropyl methylcellulose phthalate (HPMCP), and the at least one alkaline compound is ammonia. ### Claim 9 (depends on 8) The composition according to claim 8, further comprising at least one pharmaceutically acceptable or food acceptable plasticizer and/or coloring agent. ### Claim 10 (depends on 1) The composition according to claim 1, wherein the at least one acid resistant polymer is cellulose acetate phthalate (CAP), and the at least one alkaline compound is ammonia. ### Claim 11 (depends on 10) The composition according to claim 10, further comprising at least one pharmaceutically acceptable or food acceptable plasticizer and/or coloring agent. ### Claim 12 (depends on 1) The composition according to claim 1, wherein the at least one acid resistant polymer is hydroxypropyl methylcellulose acetate succinate (HPMCAS), and the at least one alkaline compound is ammonia. ### Claim 13 (depends on 12) The composition according to claim 12, further comprising at least one pharmaceutically acceptable or food acceptable plasticizer and/or coloring agent. ### Claim 14 An acid resistant banding composition for acid resistant two piece hard capsules, comprising: at least one acid resistant polymer selected from the group consisting of hydroxypropyl methylcellulose phthalate (HPMCP), cellulose acetate phthalate (CAP), and hydroxypropyl methylcellulose acetate succinate (HPMCAS); ammonia; and water. ### Claim 15 A method for the preparation of an acid resistant banding solution, comprising: dispersing at least one acid resistant polymer in water under mixing; and adding at least one alkaline compound progressively under gentle stirring until the at least one acid resistant polymer is dissolved. ### Claim 16 (depends on 15) The method according to claim 15, wherein the preparation of the banding solution is carried out at room temperature. ### Claim 17 (depends on 15, 16) The method according to claim 15 or 16, further comprising the step of adjusting viscosity of the banding solution by adjusting the polymer concentration of the solution. ### Claim 18 (depends on 17) The method according to claim 17, wherein the viscosity is from about 50 cP to about 10,000 cP at room temperature. ### Claim 19 (depends on 18) The method according to claim 18, wherein the viscosity is from about 100 cP to about 5000 cP. ### Claim 20 (depends on 19) The method according to claim 19, wherein the viscosity is from about 1500 cP to about 3100 cP. ### Claim 21 (depends on 16, 17, 18, 19, 20) The method according to any one of claims 16 to 20, further comprising adding to the banding solution at least one pharmaceutically acceptable or food acceptable plasticizer and/or coloring agent. ### Claim 22 (depends on 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14) An acid resistant hard capsule comprising an acid resistant banding composition according to any one of claims 1 to 14 for use for oral administration of at least one of pharmaceuticals, veterinary products, foods, and dietary supplements to humans or animals. ### Claim 23 (depends on 22) The capsule according to claim 22, wherein the capsule comprises a dip molded or injection molded hydroxypropylmethylcellulose (HPMC) acid resistant hard capsule. ### Claim 24 A method for banding an acid resistant hard capsule with an acid resistant banding composition comprising at least one acid resistant polymer, at least one alkaline compound, and water comprising: determining the desired banding composition amount; measuring the banding composition required; and applying the banding composition to the acid resistant capsule. ### Claim 25 (depends on 24) The method according to claim 24, wherein the capsule comprises a dip molded or injection molded hydroxypropylmethylcellulose (HPMC) acid resistant hard capsule. ### Claim 26 (depends on 24) The method according to claim 24, wherein the acid resistant polymer is selected from the group consisting of methacrylic acid copolymers; cellulose acetate phthalate (CAP), cellulose acetate trimellitate (CAT), hydroxypropylmethylcellulose acetate succinate (HPMCAS), hydroxypropylmethylcellulose phthalate (HPMCP), carboxy methyl ethyl cellulose (CMEC), polyvinyl derivatives, and mixtures thereof. ### Claim 27 (depends on 24) The method according to claim 24, wherein the at least one alkaline compound is selected from the group consisting of sodium bicarbonate, sodium carbonate, potassium carbonate, potassium bicarbonate, sodium hydroxide, tri sodium phosphate, sodium perborate, potassium hydroxide, lithium hydroxide, lithium carbonate, lithium bicarbonate, ammonium carbonate, ammonium bicarbonate, ammonium hydroxide, ammonia, and mixtures thereof. ### Claim 28 (depends on 24) The method according to claim 24, wherein the at least one acid resistant polymer is hydroxypropylmethylcellulose phthalate (HPMCP), and the at least one alkaline compound is ammonia. ### Claim 29 (depends on 28) The method according to claim 28, further comprising at least one pharmaceutically acceptable or food acceptable plasticizer and/or coloring agent. ### Claim 30 (depends on 24) The method according to claim 24, wherein the at least one acid resistant polymer is cellulose acetate phthalate (CAP), and the at least one alkaline compound is ammonia. ### Claim 31 (depends on 30) The method according to claim 30, further comprising at least one pharmaceutically acceptable or food acceptable plasticizer and/or coloring agent. ### Claim 32 (depends on 24) The method according to claim 24, wherein the at least one acid resistant polymer is hydroxypropylmethylcellulose acetate succinate (HPMCAS), and the at least one alkaline compound is ammonia. ### Claim 33 (depends on 32) The method according to claim 32, further comprising at least one pharmaceutically acceptable or food acceptable plasticizer and/or coloring agent. ### Claim 34 (depends on 24) The method according to claim 24, wherein the banding composition is applied to the capsule at room temperature.